Are Supplements Safe?

A growing number of supplements are spiked with prescription, banned, or untested drugs that you won't see listed on the label

In 2014, Fernando del Real was living the life he'd always envisioned for himself. He was 35 years old with a wife and two young boys who bounced around his Azusa, California, home like ping-pong balls. But his time, once spent on workouts and jiu-jitsu, was now filled by Disneyland and Legos. He still weighed around 180 pounds, but it was a softer 180 than he'd known in his 20s.

Just as he was feeling his fitness waning, he noticed that one of his buddies was muscling up fast. The friend recommended a supplement that he said was helping him make rapid gains at the gym. So in mid-November, del Real visited a local nutrition shop looking for the same product. They didn't have it; the sales assistant suggested another product called Tri-Methyl Xtreme.

The bottle listed ingredients that del Real had never heard of, but they were described to him as "prohormones" that were safe and legal. The salesperson also recommended a product called Liver Health. "There were no warning labels," del Real says. "I didn't feel that anything bad would happen taking something that came from a store." He paid $80 and started taking the pills.

Over the next month, the results exceeded his expectations. Four to six days a week, he lifted weights for an hour or two, and his arms and legs gained definition as he packed on 12 pounds of muscle. He benched 295 pounds—a new max. (To build muscle fast without any sketchy supplements, try MetaShred Extreme from Men's Health. It contains 8 metabolic bodybuilding workouts designed to help you gain muscle and lose fat at the same time.)

But toward the end of December, other symptoms emerged. His energy plummeted; he could barely drag himself out of bed to work his shift as a freight conductor with the BNSF Railway. His scrotum felt tight. When he stepped on a treadmill at the gym, his legs felt leaden.

He quit the pills after four weeks. Then one day in early January of 2015, a coworker stopped him and told him his eyes were yellow. "I looked in the mirror," del Real says, "and it freaked me out." To his astonishment, two golden marbles stared back at him.

Americans love supplements so much that they spent over $27 billion on pills and powders in 2016, with the product list rocketing from about 4,000 in 1994 to more than 55,000 now. Hundreds of millions of customers turn to supplements in an effort to increase their vitamin intake or maintain their health. Others take herbal cocktails that promise to aid weight loss, enhance sex, or boost muscle gain. The latter two are primarily marketed to men, and sometimes the more physically demanding your life, the more attractive supplements become.

When Harris Lieberman, Ph.D., a researcher with the U.S. Army, set about to determine how many soldiers were taking supplements, he was surprised to learn that more than half of them did. Multivitamins are at the top of the list, but muscle boosters are also "extremely popular," Lieberman says. Like del Real, many men think of supplements as natural shortcuts to enhance strength.

Oversight of the supplement industry falls to the FDA, which regulates the products more like food than drugs. So even though supplements sit next to allergy meds and ibuprofen at your drugstore, they don't have to comply with the same testing requirements for safety and effectiveness. That makes supplement sales an enticing commercial venture for opportunists with zero expertise.

More than 7,000 supplement companies are registered in the United States, and the list certainly includes long-established firms that are trying to do the right thing. But here's the problem: Scores of speculators have popped up, selling products with ingredients that are untested or illegal—or both. Consumers are paying the price. A recent study has identified supplements as an emerging cause of drug-induced liver damage in the United States, rising from 7 percent of cases in 2004 to 20 percent today. Another study, published in the New England Journal of Medicine, estimates that supplement ingestion accounts for about 23,000 emergency room visits each year.

Spooked by his yellow eyes, del Real called his sister-in-law, a physician assistant. She asked if he was on anything he shouldn't be.

"I was taking something new," he told her, "but I bought it at a store." Like him, she was reassured at the thought that his pills came retail. She suggested he might be severely dehydrated.

Even when extra water didn't help, he still resisted seeing a doctor, despite his wife's urging. "I'm like, 'I'm fine, I'm fine, I'll just drink water,' " he says. Finally, a few days after that scary observation by his coworker, del Real went to an ER. Testing revealed that his liver enzymes were sky-high. He was diagnosed with jaundice and sent home.

Soon he began to itch. It felt like the bites from a thousand mosquitoes. He had nightmares about pouring gas on his arms and lighting them on fire. He woke up in sheets soaked with sweat, bleeding from scratching.

Right before Valentine's Day, after del Real had dropped 30 pounds in a month, the doctor told him to report to the hospital for an MRI. "My dad, who was 70, took me there, and I had no strength to get out of the car," del Real says. "We both started crying. I'm never going to forget it. I'd maybe seen my father cry one time other than that in my life."

The next morning he was admitted. "The doctors told me that if they didn't see a change within a day or two they were going to put me on the liver transplant waiting list."

His doctors believe the pills he took contained steroids, which would be illegal. By law, a supplement must contain at least one or a combination of the following: vitamin, mineral, amino acid, herb/botanical, or other dietary substance used by the body. But a growing number of supplements are spiked with prescription, banned, or untested drugs that you won't see listed on the label. Some brands have provoked concerns because of undisclosed ingredients, such as the stimulant DMAA (a.k.a. geranium extract) or, more recently, sibutramine, a banned prescription weight loss drug.

Sometimes even the supplements themselves have harmful, unnaturally high doses of a natural substance. Green tea extract, a common ingredient in weight loss pills, is being increasingly indicted for liver damage in people who may have thought a capsule was no more dangerous than a strong cup of tea.

Legislation passed in the 1990s dictates that the FDA can police products sold as supplements (largely through random spot checks of inventory) only after people are buying them or if people like del Real get sick. Given the sheer number of companies and products, the often whack-a-mole nature of enforcement means that manufacturers who don't follow the rules know the odds of getting away with it are in their favor.

When the FDA receives reports that a product could be harmful, it warns the public on its website and sends manufacturers and sellers a request to pull their inventory. The warning about Tri-Methyl Xtreme was posted on April 13, 2015, alerting that the product was "linked to serious liver injury."

When Men's Health tried to purchase Tri-Methyl Xtreme online in December 2016, a site recommended Quad-Methyl Xtreme instead, and sent it. Both appear on the High Risk Dietary Supplements list kept by the U.S. Anti-Doping Agency.

MH nutrition advisor Mike Roussell, Ph.D., analyzed the labels. "Unless you have a chemistry degree, it's difficult to understand what's in the products and what the differences are between the two," says Roussell. "These two products are very similar. Tri-Methyl had three listed ingredients derived from steroids; Quad had four. These types of compounds, commonly known as prohormones, act very similar to steroids and can carry the same if not greater risks as steroids."

Notably, those increased risks include irreversible organ damage, heart attack and stroke, shrinkage of the testicles, breast enlargement, and infertility in men.

When MH sent the $100-per-bottle product to NSF International, an independent lab, testing revealed that Quad-Methyl Xtreme contained none of the steroids listed as ingredients. The main active ingredient turned out to be turmeric. "More often we find muscle-building products spiked with anabolic steroids not listed on the label," says John Travis, senior research scientist with NSF.

Some companies bypass the long chemical names of ingredients and list "oral steroids" on their labels, but make no mistake: Selling anabolic steroids in any form isn't legal, says Amy Eichner, Ph.D., special advisor on drug reference and supplements at the U.S. Anti-Doping Agency. Companies do it anyway, she says, probably because they've decided that the monetary reward from selling the product is worth the risk of getting caught. Selling steroids under the guise of dietary supplements has been an ongoing problem, she says, and "it's maddening that we're still in the same place."

Critics often argue that the government either can't or doesn't do enough. Since 2007, the FDA has identified more than 782 potentially risky supplements; the agency issued more than 200 recalls in 2015 and 2016 alone. But a study published in 2013 found that only 70 percent of dodgy products discovered by the FDA between 2004 and 2012 had been recalled.

Supplement watchdog Pieter Cohen, M.D., of Harvard Medical School, has found that even a recall doesn't necessarily protect consumers. Dr. Cohen set out to investigate whether recalled products remained for sale online. The results, published in 2014, startled him: He was still able to purchase about 10 percent of the products recalled for safety between 2009 and 2012. Of those, 67 percent still contained the risky ingredients. The products had basically the same labels, with no adjustments in supplement or company name and only slight packaging changes. "This demonstrates that recalls are inadequate to remove the most dangerous supplements from store shelves," Dr. Cohen says.

As del Real waited in a hospital bed praying his liver would recover, he received more distressing news. His kidneys were failing. "I was scared," he says. "I've got kids." Gradually, though, his organs began to repair themselves. After more than a week in the hospital, he returned home to recuperate, but he wasn't able to return to work for another three months.

Once del Real got healthier, he got angry. He hired Los Angeles attorney Tenny Mirzayan to sue the distributor, the Las Vegas-based Extreme Products Group LLC, and an associated company called Brand New Energy Inc. That is, if Mirzayan could find them. The phone number on the bottle had been disconnected. A process server who drove to the official address repeatedly for a week found a house in a gated community, with unopened mail piled up.

Mirzayan Google-mapped the address on the incorporation documents listed with the California Secretary of State. It appeared to be a retro clothing store that looked abandoned. She describes how she scoured Facebook posts, message boards, LinkedIn, and even nutrition forums for clues to the people behind the company. "These companies pop up, put no money down, and incorporate somewhere like Nevada, where the laws are more lax." She eventually located the sellers. And where were they getting their raw goods? As far as she can tell, China.

Lawyers representing Brand New Energy, which was named in the lawsuit, would not comment on the case. The other supplement, Liver Health, was made by now defunct VIT Labs and discontinued five years ago, according to attorney Alexandra Buechner. She says they're still trying to figure out how it was available for purchase years later.

Many health experts would like tighter safeguards, especially on products sold for weight loss and muscle gain. "Supplement manufacturers need to be required to do the same kind of safety and efficacy studies as drugs and to provide that data to the FDA," says S. Bryn Austin, Sc.D., of Boston Children's Hospital. "They can't be treated the same as food products." New federal laws are unlikely, but in a recent research paper, Austin outlined measures that individual states can take, such as banning sales of weight loss and muscle building supplements to minors and moving these products behind the counter.

Supplement industry representatives oppose new laws but do fear that bad operators taint the whole field. They urge stronger, quicker FDA action when illegal products are found. Industries improve through carrots and sticks. "The FDA's job is primarily to administer sticks, and they've got to administer sticks in a way that is swift and sends a good message. That's been lacking," says Daniel Fabricant, Ph.D., executive director of the National Products Association.

If you're considering a supplement, follow these guidelines: Stick to products made by known, larger companies. "If you can find a manufacturer that is larger and more well established, you're going to be better off," says attorney Tim Blood, who works on supplement lawsuits. Look for a seal from NSF International or the Natural Products Association, which indicates that the product has been tested for safety and potency and that the ingredients listed are in the product. (The NSF Certified for Sport app lists supplements that passed safety testing.)

Of course, many supplements on the market are combinations of multiple ingredients and especially difficult to evaluate as a result, says Lieberman. Very few scientific studies have been done on combinations of ingredients. In fact, there's only limited high-quality research on most individual ingredients. When different ingredients are combined, the side effects can't necessarily be predicted. Dietary supplements and combination products may also interact with medications, Lieberman says.

These days, del Real won't even take so much as a vitamin. "I'd like to think I'm back to normal, but I know the damage to my liver is permanent," he says. As a result of his ordeal, he now has high blood pressure—at age 37. "I think the thing that bugs me the most is just like the emotional part of it. It caused my family a lot of pain. Even talking about it, I get goose bumps."

THREE SMARTER SUPPLEMENTS

They're not all dangerous. Some can help you reach your health and muscle goals.

Protein Powder
It isn't easy to eat 1 gram of protein per pound of your target weight every day, which is what MH nutrition advisor Alan Aragon recommends. A daily shake can help. Look for a brand that contains fast-acting whey protein to fuel muscle growth. If you're trying to stick to a low-carb eating plan, seek out products without maltodextrin.

Creatine
Consuming creatine daily is a safe and scientifically proven way to enhance the muscle growth sparked by your strength training, Aragon says. Aim for 15 to 20 grams of creatine a day for five days to preload your system. Then consume 2 to 4 grams a day. Don't be seduced by fancy formulations. Standard creatine monohydrate works just as well.

Multivitamin
Think of your multi as insurance for nutritional gaps in your diet, says Chris Mohr, Ph.D., R.D. Research reveals a surprising benefit: Taking a daily multi may help ease feelings of stress, anxiety, and depression by about 30 percent. Take it with lunch and you'll absorb more nutrients. Choose one that hits 100 percent of the RDAs, not megadoses.

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